The present invention relates to devices for securing tracheostomy tubes and oral endotracheal tubes and more particularly, relates to an improved tracheostomy tube and oral endotracheal tube holder for retaining such tubes in operational, patient contact.
A tracheostomy tube is a curved tube which is inserted into a tracheostomy stoma. While there are several different types of tubes, they all have similar parts. The main parts of a tracheostomy tube are the outer tube, the inner tube or inner cannula and the obturator. The obturator is only used to insert the outer tube and is removed once the outer tube is in place. The outer tube typically has a support base flange and ties to secure around the patient's neck. In use, the inner cannula is inserted and removably locked in place after the obturator is removed. The inner cannula is withdrawn for brief periods to be cleaned and acts as a removable liner for the more permanent outer tube. Tracheostomy tubes may be cuffed, uncuffed or fenestrated. A cuff is a soft balloon around the tracheostomy tube near the distal end that can be inflated to hold the tube in place.
Prior to 1983, the only method being used to any extent to secure a tracheostomy tube to a patient's neck was strips of cotton fabric split at either end and then tied through the openings in the flange of the trache. Although reliable, it was extremely time consuming and tended to fray at the ends and roll up in a rope configuration which caused irritation to the patient's neck. Wapner U.S. Pat. No. 4,331,144 addressed these problems. Wapner U.S. Pat. No. 4,331,144 discloses a band which encircles the head and secures to itself using a hook and loop fastener. It also employs strips which thread through the slits in a trache flange and then secures back onto itself using hook and loop fasteners. While certainly functional, the Wapner device is also time consuming and can be extremely difficult to employ if the flange of the trache holder is pulled into folds of flesh as is often the case with overweight patients. To overcome this problem, the inward force normally required to hold trache tube within the trachea must be reduced in order to allow the flanges to ride above the flesh folds. This scenario can result in the trache tube actually coming out of the stoma in the trachea. Examples of other tracheostomy tube holders are shown in U.S. Pat. No. 5,529,062 issued to T. N. Byrd on Jun. 25, 1996 and U.S. Pat. No. 5,671,732 issued to M. L. Brown on Sep. 30, 1997.
With regard to securing oral endotracheal tubes, the generally practiced method is to use tape which is wrapped around a patient's neck and is then wrapped around the tube itself before being adhered to a patient's cheek for anchoring purposes. This technique is also time consuming and the tape needs to be replaced frequently due to saliva and blood which decreases the adhesive ability of the tape. Addison U.S. Pat. No. 3,924,636 and Wapner U.S. Pat. No. 4,548,200 illustrate attempts to standardize and simplify the securing of oral endotracheal tubes. Wapner U.S. Pat. No. 4,548,200 discloses a device which employs a hook and loop fastener with adhesive backing which encircles the patient's head. Since it employs a soft material in the region of the mouth, the tube holder would become stained and slippery in short order and would necessitate frequent replacement. Further, the device of Wapner '200 is not applicable to a tracheostomy tube. Addison U.S. Pat. No. 3,924,636 discloses a plastery with a central opening and a holding strap that is self-adhering. The Addison device, since it can stick to the patient's face by means of an adhesive plastery, cannot be used if the patient has any type of facial injury since it cannot be taped over a wound site, and the elliptical central opening does not prevent any lateral tube migration. It is also not applicable to a tracheostomy tube.
The present invention is specifically directed to an improvement in the type of holder shown in my U.S. Pat. No. 5,471,980 entitled "Tracheostomy Tube and Oral Endotracheal Tube Holder" issued on Dec. 5, 1995. This patent discloses a device for supporting and retaining a tracheostomy tube or endotracheal tube in operational patient contact and includes a support strap, a tube support member having an opening formed therein and at least one resilient tube engagement member projecting into the tube receiving opening for contacting and frictionally retaining a tube in the opening. As is typical, the tracheostomy tube for which this holder is designed includes a support flange with openings for receiving ties and a barrel, at one end of the tube adjacent to the support flange, including a lip extending along the opening of the tube. The tube holder comprises a generally flat, elongate main body portion including a tube receiving opening at its midpoint and first and second straps attached to its ends. The tube receiving opening includes has a plurality of resilient tube engagement members. The main body of the tracheostomy tube holder is approximately the same size and configuration as the support flange of the tracheostomy tube.
In use, the main body is positioned against the support flange so that the barrel of the tracheostomy tube is received through the tube receiving opening and secured therein by the tube engagement members. Thus, the holder is positioned over and covers the support flange and is securely mounted to the tracheostomy tube. Unlike prior art methods for securing the tracheostomy tube to the patient which require attaching ties directly to the support flange, the support strap of my patented device is connected to the holder which securely holds the holder and tracheostomy tube in place on the patient. The patient is connected to a ventilator via a circuit which is connected to an inner cannula tube including locking means which extend into the underside of the lip and lock onto the lip of the barrel of the tracheostomy tube to connect the inner cannula and the tracheostomy tube. In order to attach the tube to the flange while allowing the tube to move relative to the flange, the tracheostomy tube typically includes articulations or pivots on the exterior of the tube adjacent to the barrel, which extend outward onto the surface of the support flange forming raised portions on the flange adjacent to the barrel. The articulations increase the flexibility of the flange relative to the tube. Thus, the tube may move relative to the flange in response to movement of the patient's head and neck and provide for better comfort of the patient without the possibility of disconnection between the support flange and the tracheostomy tube.
While the tracheostomy tube holder shown in U.S. Pat. No. 5,471,980 provides a simple and effective means for holding a tracheostomy or endotracheal tube in operational patient contact, one disadvantage is that the articulations or pivots of the tube and flange do not permit the main body of the tube support member and the support flange to be positioned completely flush with one another. Because prior art methods typically utilize the openings on the support flange to secure the tracheostomy tube to the patient, the locking means of the cannula is designed to lock onto the lip of the barrel of the tracheostomy tube with little clearance between the locking means and the support flange. Therefore, because the main body and flange are not flush, the addition of the main body of the holder between the support flange and the teeth of the inner cannula in the area where the teeth lock onto the underside of the lip of the barrel may impair the grip of the teeth on the tracheostomy tube and prevent a secure connection between the inner cannula, and the tube and the patient and the ventilator.
One method of addressing this serious problem is shown in my improved tracheostomy holder at FIGS. 1-3 (PRIOR ART) of this application. The improved tracheostomy holder includes a main body portion having a tube receiving opening at its midpoint and straps attached to its ends. The tube receiving opening includes a resilient tube engagement member which may be removed or used to secure an oral endotracheal tube or further secure a tracheostomy tube in place. The improved tracheostomy holder also includes an additional strap for anchoring the strap in place and means for securing the anchor strap around the circuit after the inner cannula is locked in place and the circuit connecting the ventilator thereto is attached to the inner cannula. In addition, the main body may also be formed of an anti-microbial material, such as, by way of example, a plastic impregnated with a broad spectrum anti-microbial agent, for reducing bacteria at the tracheostomy opening and reducing the risk of infection.
In order to permit a secure connection between the inner cannula and the tracheostomy tube, the main body of the improved tracheostomy holder has a back surface including shallow, triangular-shaped recesses or indentations which allow the main body to rest completely flush with the support flange of the tracheostomy tube. In use, the support flange is positioned flush with the main body so that the barrel of the tracheostomy tube is received through the tube receiving opening and secured therein by the tube engagement member and the device is secured to the patient with the straps attached thereto. When the tube is in place for connection to the inner cannula, the articulation or pivots of the tube and support flange mate with and project into the shallow, triangular-shaped recesses on the back surface of the main body so that the main body and support flange of the tracheostomy tube are completely flush with one another. Because the main body and support flange are completely flush, the grip of the teeth of the inner cannula on the tube is not impaired for providing a secure connection between the patient and the ventilator.
In an ongoing effort to increase patient comfort, there has recently been an improvement to tracheostomy tubes. The improvement provides tracheostromy tubes with a support flange constructed of a softer, more flexible yet durable material such as, by way of example, rubberized plastic. Because the support flange rests directly against the patient's throat, the use of a softer, more flexible material may substantially reduce the irritation which may be caused by the contact of the support flange with the patient's skin. While the improved support flange remains substantially the same shape, the use of the softer, more flexible material has increased the thickness of the support flange. Therefore, the articulations or pivots heretofore known to be on the exterior of the tube and flange are now encompassed within the interior of the thicker support flange and there are no raised portions on the exterior of the flange adjacent to the barrel of the tube.
While my improved tracheostomy holder may be ideal for use with tracheostomy tubes which include articulations or pivots on the exterior of the tube adjacent to the barrel forming raised portions on the support flange adjacent to the barrel, this device has not proven effective with the recently improved tracheostomy tubes which include the thicker, flexible, soft support flange. Although the main body is flush with the support flange, the improved, thicker, flexible support flange effectively decreases the clearance from the front of the flange to the underside of the lip of the barrel leaving no space for the addition of the main body between the flange and the teeth of the cannula for allowing the teeth to lock onto the lip of the tracheostomy tube. Further, the shallow, triangular-shaped indentations on the back surface of the main body do not address the problem since the articulations of the improved flange are formed within the interior of the flange and no longer extend into or mate with the indentations of the device. Thus, the grip of the cannula teeth on the improved tracheostomy tube with a flexible support flange is impaired or completely prevented by this type of tracheostomy tube holder including indentations in the back surface of the main body. Therefore, there is a need for an improved tracheostomy or endotracheal tube holder which provides a means for allowing the teeth of the inner cannula to securely grip a tracheostomy tube without impairment, regardless of the thickness of the support flange, while maintaining the flexibility of the flange and comfort of the patient and providing a simple and effective means for holding a tracheostomy or endotracheal tube.